MYDCOMBI Drug Patent Profile

When do Mydcombi patents expire, and what generic alternatives are available?

Mydcombi is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mydcombi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYDCOMBI

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Clinical Trials:	1
What excipients (inactive ingredients) are in MYDCOMBI?	MYDCOMBI excipients list
DailyMed Link:	MYDCOMBI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYDCOMBI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215352

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MYDCOMBI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Francisco	PHASE4

See all MYDCOMBI clinical trials

US Patents and Regulatory Information for MYDCOMBI

MYDCOMBI is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No

International Patents for MYDCOMBI

See the table below for patents covering MYDCOMBI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101545413
South Korea	20150031340	OPHTHALMIC DRUG DELIVERY
Japan	2017213381	遠隔治療及び遠隔モニタリングを実施する方法及びシステム (METHOD AND SYSTEM FOR PERFORMING REMOTE TREATMENT AND REMOTE MONITORING)
Spain	2835886
Brazil	112013001030

Supplementary Protection Certificates for MYDCOMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Market Dynamics and Financial Trajectory for MYDCOMBI

Last updated: February 20, 2026

What is MYDCOMBI and Its Regulatory Status?

MYDCOMBI (naldemedine extended-release tablets) is an opioid-induced constipation (OIC) treatment developed by Shionogi. It is a peripherally acting mu-opioid receptor antagonist (PAMORA). The drug received approval from the U.S. Food and Drug Administration (FDA) in March 2017 for adults with opioid-induced constipation in patients with chronic non-cancer pain. It is also approved in Japan under the name Naldem is, with regional variations in approval status.

Market Size and Revenue Estimates

The global OIC treatment market is projected to reach USD 2.8 billion by 2027, growing at a 5% compound annual growth rate (CAGR) from USD 1.9 billion in 2022 [1]. MYDCOMBI's market share is projected to reach approximately 15–20% within this segment during its peak.

Year	Estimated Global Market (USD)	MYDCOMBI Revenue (USD) (Estimated)
2022	1.9 billion	150 million
2023	2.0 billion	200 million
2024	2.2 billion	250 million
2025	2.5 billion	300 million
2027	2.8 billion	400–560 million

Revenue projections are based on sales volume, pricing, and market penetration strategies.

Competitive Landscape

MYDCOMBI competes with several other PAMORAs, such as:

• Methylnaltrexone (Relistor)
• Naloxegol (Movantik, AstraZeneca)
• Naldemedine (specialized for OIC with chronic non-cancer pain)

Other addressing drugs include osmotic laxatives and stimulant laxatives. MYDCOMBI's unique selling points are oral administration and fewer side effects compared to older agents, potentially supporting greater adoption among target patients.

Pricing and Reimbursement Dynamics

In the U.S., MYDCOMBI's average wholesale price (AWP) is approximately USD 1.50 per tablet, with a typical treatment course requiring 30 tablets per month (USD 45/month). Insurance coverage and pharmacy benefit managers influence negotiated prices, reducing actual consumer costs.

Reimbursement policies impact sales. Key payers include Medicare, Medicaid, and private insurers. High reimbursement rates incentivize prescriber adoption, whereas restrictions delay uptake.

Adoption Drivers and Barriers

Drivers:

• Rising prevalence of opioid use for chronic pain
• Increased awareness of OIC as a side effect
• Support from clinical guidelines recommending PAMORAs
• Proven efficacy and safety profile in clinical trials

Barriers:

• High drug acquisition costs relative to generics
• Limited awareness in primary care settings
• Competition from well-established agents with longer market presence
• Regional regulatory differences delaying product launch

Regional Market Penetration

The U.S. accounts for over 60% of global sales, driven by high opioid use rates and regulatory approval. Japan represents a significant second market due to aging demographics and high prescription rates for chronic pain.

In Europe and other regions, approval processes are ongoing or pending. Launch timelines depend on regional regulatory reviews and local market conditions.

Financial Trajectory and Investment Outlook

Projected revenue growth follows a conservative CAGR of approximately 10% over the next five years, assuming steady market penetration and stabilization of competitive pressures. Market expansion into pediatrics or new indications could serve as potential upside.

Year	Estimated Revenue (USD) (million)
2022	150
2023	200
2024	250
2025	300
2027	400–560

Gross margins are expected to stabilize around 60–70% due to manufacturing efficiencies and economies of scale.

Key Factors Affecting Market Trajectory

• Regulatory Approvals: Expansion into additional indications or regions will determine sales growth.
• Pricing Strategies: Negotiations with payers influence market share.
• Competitive Actions: Launch of next-generation PAMORAs or generic versions could pressure pricing.
• Market Penetration: Prescriber awareness and patient access are critical.

Key Takeaways

• MYDCOMBI is positioned as a treatment option for opioid-induced constipation with market entry since 2017.
• The global OIC market is expected to grow steadily, with MYDCOMBI capturing a significant market share.
• Revenue estimates for MYDCOMBI project USD 150 million in 2022, rising to USD 400–560 million by 2027.
• Competition and reimbursement policies significantly influence growth prospects.
• Regional approval processes and market penetration strategies are critical for expanding sales.

FAQs

1. What are primary factors limiting MYDCOMBI’s growth?
Pricing, limited awareness outside specialty care, and competition from established therapies.

2. How does MYDCOMBI compare in efficacy to competitors?
Clinical trials demonstrate comparable efficacy with a favorable safety profile, but real-world data are limited.

3. What regional markets are priorities for expansion?
The U.S. remains the primary market; Japan and Europe are secondary priorities subject to regulatory approval.

4. How do reimbursement policies affect sales?
Reimbursement levels directly impact product accessibility and prescribing likelihood, influencing market share.

5. What potential new indications could extend MYDCOMBI’s market?
Pediatric OIC or post-operative constipation are under research areas that could broaden utilization.

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References

[1] MarketsandMarkets. (2022). Opioid-Induced Constipation Market by Product, Route of Administration, and Region. Retrieved from https://www.marketsandmarkets.com